Hipoenergetic Effect of Diet Associated or Not With the Consumption of Coconut Flour in Women With Overweight

Obesity Clinical Trial

Official title:

Effect of Hipoernergetic Diet Combined or Not With Coconut Flour on Overweight Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152111
• Other study ID #: 05155812.2.0000.5257
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: June 22, 2014
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate the effect of weight loss with diet combined coconut flour consumption improvement weight loss and reduction in glucose, cholesterol in obese women.

Description:

This is a clinical trial with two groups, one receiving hipoenergetic diet for 180 days and another group with hipoenergetic diet for 90 days, a washout period for another 90 days and another period for another 90 days diet meal plus hipoenergética coconut. In order to assess body mass, waist circumference and neck, assess the lipid profile, glucose and uric acid.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

women > 20 years old BMI >25 Kg/m²

Exclusion Criteria:

Performing diets and / or making use of drugs for the reduction of body weight; Supplements of any kind; Pregnant and lactating women; In use of statins; With voluntary water restriction. -

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Obesity

Intervention

Dietary Supplement:
• Coconut flour
Patients 9 months following treatment, starting at 3 months with diet hipoenergetica 3 months washout and sixth month diet hiponergetic more coconut flour.

Behavioral:
• Diet
Patients were instructed to follow the dietary treatment for 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometry	To evaluate the effect to coconut flour in the improvement of weight, waist circumference and neck circumference in voluntary overweight and obesity	9 months	No
Secondary	Lipid profile	To evaluate the effect the coconut flour in lowering total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.	9 months	No
Secondary	Quality of the diet	To evaluating the effect of treatment on the nutritional quality of the diet	9 months	No